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A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

Generalized Anxiety Disorder Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.

Clinical Trial Summary

The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.

Clinical Trial Description

The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05970510
Study type Interventional
Source Luye Pharma Group Ltd.
Contact Zhang Hongyan
Phone 13601237138
Email hongyanzhang@bjmu.edu.cn
Status Recruiting
Phase Phase 3
Start date July 12, 2023
Completion date April 30, 2026
View Details
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